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Protein-Protein Interaction Inhibitor

AO-252 for Cancer

Phase 1

Recruiting

Research Sponsored by A2A Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with TNBC, platinum-resistant HGSOC, primary peritoneal cancer, and/or fallopian-tube cancer, or serous endometrial cancer as described below

Patients with TNBC must have histologically or cytologically confirmed metastatic or locally recurrent unresectable TNBC per American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) criteria, with TP53 mutation/loss, and be relapsed/refractory to at least 1 line of systemic chemotherapy in the metastatic setting or be intolerant of existing therapy(ies)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

Study Summary

This trial evaluates the effectiveness, safety, and best dose of a new drug to treat a medical condition.

Who is the study for?

This trial is for adults with certain advanced solid tumors like TNBC, ovarian, peritoneal, fallopian-tube or serous endometrial cancer. Participants must have specific genetic mutations (TP53), be past a first line of chemotherapy and not suitable for standard treatments. They need to be relatively healthy otherwise, not pregnant or breastfeeding, willing to use contraception and without recent other cancers or serious illnesses.Check my eligibility

What is being tested?

The study tests AO-252, an oral drug for advanced solid tumors. It aims to find the safest and most effective dose. The focus is on how well patients tolerate it and its impact on their cancer.See study design

What are the potential side effects?

While the side effects of AO-252 are being studied in this trial and aren't fully known yet, common risks may include reactions at the medication site, fatigue, nausea or other digestive issues as typically seen with new cancer drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have TNBC, HGSOC, primary peritoneal, fallopian-tube, or serous endometrial cancer.

Select...

My TNBC is confirmed, cannot be surgically removed, has a TP53 mutation, and hasn't responded to or I can't tolerate at least one chemotherapy.

Select...

I can carry out all my usual activities without help.

Select...

My cancer is resistant to platinum treatment, has spread, and lacks other treatment options.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety Assessments [Dose escalation and Dose expansion]

Safety Assessments [Dose escalation]

Secondary outcome measures

Antitumor Activity of AO-252 [Dose escalation and Dose expansion]

Pharmacokinetic Profile of AO-252 [Dose escalation and Dose expansion]

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention

After doses are decided in Part 1, participants entering part 2 will be assigned to a dose level.

Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention

Participants will be assigned to dose levels.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

A2A Pharmaceuticals Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings to join this experiment?

"Affirmative. The clinical trial information available on the website of clinicaltrials.gov indicates that recruitment is still open for this experiment, which was first posted in November 2nd 2023 and edited most recently on 13th of the same month. This investigation requires 144 patients to be enrolled across two sites."

Answered by AI

What potential risks are associated with the Part 1: Dose Escalation stage of this experiment?

"Given this is a Phase 1 trial, meaning there are limited data points regarding efficacy and safety, our team at Power assigned Part 1: Dose Escalation a score of 1."

Answered by AI

What is the cap on participant numbers for this research endeavor?

"That's right. According to the information on clinicaltrials.gov, this research is presently recruiting patients as of November 13th 2023 and was initially posted two weeks prior on November 2nd 2023. The study requires 144 participants from 2 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors

2023. "A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06136884.